Phenytoin immunoassay measurements in serum samples from patients with renal insufficiency: comparison with high‐performance liquid chromatography

Journal of Clinical Laboratory Analysis - Tập 21 Số 2 - Trang 119-123 - 2007
María J. Tutor‐Crespo1, Jesús Hermida1, J. Carlos Tutor1
1Laboratorio Central, Hospital Clínico Universitario, Santiago de Compostela, Spain

Tóm tắt

AbstractThe debate continues regarding the possible interference of phenytoin metabolites in phenytoin immunoassays, and its clinical importance for patients with renal failure. The aim of this study was to compare the results obtained using the Abbott fluorescence polarization immunoassay (FPIA), Dade enzyme‐multiplied immunoassay technique (EMIT), and high‐performance liquid chromatography (HPLC) to establish the significance of the differences in conditions of renal failure. Thirty‐six adult patients who had been treated with phenytoin and whose renal function ranged from normal to severely impaired were chosen for this study. In accordance with previously established validation criteria for analytical methods for the determination of drugs, a 15% bias from the HPLC phenytoin values was considered an acceptable limit. The mean (±SEM) glomerular filtration rate (GFR) of the patients was 37.5±4.6 mL/min (range = 10–102 mL/min).The mean values found using FPIA (10.8±1.2 µg/mL) and EMIT (10.8±1.3 µg/mL) presented acceptable deviations with respect to HPLC (10.5±1.2 µg/mL), and a high correlation was found among the results (N = 36) of the different methods (r≥0.987, P<0.001). An FPIA deviation above the 15% bias limit with respect to HPLC was found only in two cases with very low serum phenytoin concentrations and low GFR values (<20 mL/min), although it does not appear to be important in terms of adjusting drug dosage. According to our data, FPIA and EMIT gave accurate results for total phenytoin in serum samples from patients with renal failure. J. Clin. Lab. Anal. 21:119–123, 2007. © 2007 Wiley‐Liss, Inc.

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Tài liệu tham khảo

Finn AL, 1981, Individualizing drug monitoring. Practical applications of drug monitoring, 63

10.1111/j.1528-1157.1988.tb04231.x

Nakajima M, 2002, Involvement of multiple UDP‐glucuronosyltransferase 1A isoforms in glucuronidation of 5‐(4′‐hydroxyphenyl)‐5‐phenylhydantoin in human liver microsomes, Drug Metab Dispos, 27, 1165

10.2133/dmpk.20.135

10.1002/cpt1979263306

10.1002/cpt1977213294

10.7326/0003-4819-94-1-59

10.1111/j.1440-1681.1976.tb02667.x

Flachs H, 1980, Renal disease may increase apparent phenytoin in serum as measured by enzyme‐multiplied immunoassay, Clin Chem, 26, 361, 10.1093/clinchem/26.2.361

Rubenstein K, 1980, Renal disease may increase apparent phenytoin in serum as measured by enzyme‐multiplied immunoassay [reply], Clin Chem, 26, 362

10.1097/00007691-198403000-00016

Roberts WL, 1993, Interference in immunoassay measurements of total and free phenytoin in uremic patients: a reappraisal, Clin Chem, 39, 1872, 10.1093/clinchem/39.9.1872

Rainey PM, 1996, Metabolite and matrix interference in phenytoin immunoassays, Clin Chem, 42, 1645, 10.1093/clinchem/42.10.1645

Datta P, 1997, Oxaprozin and 5‐(p‐hydroxyphenyl)‐5‐phenylhydantoin interference in phenytoin immunoassays, Clin Chem, 43, 1468, 10.1093/clinchem/43.8.1468

10.1309/4502-68H7-1K1B-1JVR

10.1097/01.ftd.0000164315.13825.dd

Soldin SJ, 2003, Phenytoin overview–metabolite interference in some immunoassays could be clinically important, Arch Pathol Lab Med, 127, 1623, 10.5858/2003-127-1623-POIISI

Roberts WL, 2004, Phenytoin overview–metabolite interference in some immunoassays could be clinically important, Arch Pathol Lab Med, 128, 734, 10.5858/2004-128-734-POMIIS

Soldin SJ, 2004, Phenytoin overview–metabolite interference in some immunoassays could be clinically important, Arch Pathol Lab Med, 128, 734, 10.5858/2004-128-734-POMIIS

10.1080/00365510410003723

Eksborg S, 1981, Evaluation of method–comparison data, Clin Chem, 27, 1311, 10.1093/clinchem/27.7.1311

10.1007/BF03189968

10.1053/ajkd.2002.34487

10.1093/clinchem/48.5.699

Perucca E, 1981, Therapeutic drug monitoring, 320

Warner A, 1998, Standards of laboratory practice: antiepileptic drug monitoring, Clin Chem, 44, 1085, 10.1093/clinchem/44.5.1085

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Journal of Clinical Laboratory Analysis

Tập 21 Số 2

119-123

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